Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT06076395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volume Versus Pressure Ventilation on Lung Atelectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017214', 'term': 'Laryngeal Masks'}], 'ancestors': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008397', 'term': 'Masks'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will be randomly allocated by a computer-generated list (www.randomization.com) into one of the study groups in the day of the study . The randomization sequence will be concealed in sealed envelopes and will be opened by an independent nurse. The data collector and data analysis will be blind to group assignments.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'For group A pressure control ventilation will be adjusted as follows:\n\nInspiratory pressure will be adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H 2 O and FiO2 at 0.5 providing that the maximum airway pressure will be limited to 25 cmH2O.\n\nFor group B volume control ventilation will be adjusted as follows:\n\ntidal volume (VT) adjacent to 7 ml/Kg, respiratory rate will be adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and positive end expiratory pressure (PEEP)at 4 cmH2O and FiO2 at 0.5.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-14', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative incidence of Lung atelectasis immediate post-removal of LMA.', 'timeFrame': 'immediated post removal of LMA', 'description': 'calculate lung score using lung ultrasound'}], 'secondaryOutcomes': [{'measure': 'Correlation between lung score and PaO2 /FiO2 ratio', 'timeFrame': 'From the preoperative period (T0) to 30 minutes post-extubation', 'description': 'Arterial blood gases (ABG) in different time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric cardiac catheterization', 'lung ultrasound score', 'lung atelectasis', 'LMA'], 'conditions': ['Cardiac Congenital Defects']}, 'referencesModule': {'references': [{'pmid': '12029240', 'type': 'BACKGROUND', 'citation': 'Hedenstierna G. Airway closure, atelectasis and gas exchange during anaesthesia. Minerva Anestesiol. 2002 May;68(5):332-6.'}, {'pmid': '34359177', 'type': 'BACKGROUND', 'citation': 'Stefanik E, Drewnowska O, Lisowska B, Turek B. Causes, Effects and Methods of Monitoring Gas Exchange Disturbances during Equine General Anaesthesia. Animals (Basel). 2021 Jul 9;11(7):2049. doi: 10.3390/ani11072049.'}, {'pmid': '30048331', 'type': 'BACKGROUND', 'citation': 'Chiumello D, Mongodi S, Algieri I, Vergani GL, Orlando A, Via G, Crimella F, Cressoni M, Mojoli F. Assessment of Lung Aeration and Recruitment by CT Scan and Ultrasound in Acute Respiratory Distress Syndrome Patients. Crit Care Med. 2018 Nov;46(11):1761-1768. doi: 10.1097/CCM.0000000000003340.'}, {'pmid': '35792663', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Fanjul J, Corsini I, Orti CS, Bobillo-Perez S, Raimondi F. Lung ultrasound to evaluate lung recruitment in neonates with respiratory distress (RELUS study). Pediatr Pulmonol. 2022 Oct;57(10):2502-2510. doi: 10.1002/ppul.26066. Epub 2022 Jul 12.'}, {'pmid': '36084154', 'type': 'BACKGROUND', 'citation': 'Li X, Liu B, Wang Y, Xiong W, Zhang Y, Bao D, Liang Y, Li L, Liu G, Jin X. The effects of laryngeal mask airway versus endotracheal tube on atelectasis in patients undergoing general anesthesia assessed by lung ultrasound: A protocol for a prospective, randomized controlled trial. PLoS One. 2022 Sep 9;17(9):e0273410. doi: 10.1371/journal.pone.0273410. eCollection 2022.'}, {'pmid': '24662376', 'type': 'BACKGROUND', 'citation': 'Acosta CM, Maidana GA, Jacovitti D, Belaunzaran A, Cereceda S, Rae E, Molina A, Gonorazky S, Bohm SH, Tusman G. Accuracy of transthoracic lung ultrasound for diagnosing anesthesia-induced atelectasis in children. Anesthesiology. 2014 Jun;120(6):1370-9. doi: 10.1097/ALN.0000000000000231.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized comparative study, to assess post-operative lung atelectasis by comparing calculated lung score using ultrasound between pediatric patients intubated with LMA (laryngeal mask airway) under volume versus pressure controlled modes of ventilation.', 'detailedDescription': 'The initial US scanning will be done prior to the induction of anesthesia. Induction of anesthesia using 4% sevoflurane. Adequate size LMA will be inserted after adequate depth of anesthesia adjusted.\n\nGroup A (n=25): will receive pressure-controlled ventilation (PCV). Group B (n=25): will receive volume-controlled ventilation (VCV).\n\nUS scanning and Arterial blood gases at the following:\n\n* T1(After maintenance of anesthesia).\n* T2 (One minute after applying groin bandage and before extubation).\n* T3 (10 minutes after extubation and resumption of adequate regular breathing).\n* T4 (30 min post extubation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPediatric patients undergoing cardiac catheterization procedures. Age from 2 years to 6 years of both sexes.\n\nExclusion Criteria:\n\n* Lung score at different times.\n* Age \\<2 years and \\>6 years.\n* Preoperative mechanical ventilation.\n* Heart failure (any inotropic support infusion).\n* Patients with any lung diseases( acute respiratory disease, pulmonary or lung\n* diseases).\n* Lung consolidation score ≥ 2 before insertion of LMA.\n* Any contraindication for LMA insertion (risk for aspiration, and/or airway\n* obstruction below the larynx.)\n* Procedures exceeding 120 mins duration.'}, 'identificationModule': {'nctId': 'NCT06076395', 'briefTitle': 'Volume Versus Pressure Ventilation on Lung Atelectasis', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'The Effect of Volume Controlled Versus Pressure Ventilation on Anesthesia Induced Lung Atelectasis in Pediatrics Using Laryngeal Mask Airway (LMA )During Cardiac Catheterization. A Prospective Randomized Study.', 'orgStudyIdInfo': {'id': 'MS-96-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A pressure control ventilation', 'description': 'Inspiratory pressure was adjusted to achieve an expired tidal volume of 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg, inspiratory to expiratory ratio at 1:2, PEEP at 4 cm H2O and FiO2 at 0.5 providing that the maximum airway pressure was limited to 25 cmH2O.', 'interventionNames': ['Device: LMA (Laryngeal Mask Airway)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B volume control ventilation', 'description': 'VT adjacent to 7 ml/Kg, respiratory rate was adjusted to achieve an end ETCO2 at 32-35 mmHg and I/E at: 1:2 and PEEP at 4 cm H2O and FiO2 at 0.5.', 'interventionNames': ['Device: LMA (Laryngeal Mask Airway)']}], 'interventions': [{'name': 'LMA (Laryngeal Mask Airway)', 'type': 'DEVICE', 'otherNames': ['Lung Ultrasound'], 'description': 'Pressure controlled versus Volume controlled ventilation using LMA', 'armGroupLabels': ['Group A pressure control ventilation', 'Group B volume control ventilation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Dalia Saad', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amel Hanfy Abo El- Ela', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr El Aini Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Dalia Saad Abd-El Kader', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}